FDA Device recall Z-0277-2016
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93 by Teleflex Medical, citing the defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insert….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0277-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-14 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Reason
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.
Identifiers
| code_info | Lot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0277-2016%22
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